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注册号: Registration number: |
ChiCTR2600126159 |
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最近更新日期: Date of Last Refreshed on: |
2026-06-04 15:27:10 |
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注册时间: Date of Registration: |
2026-06-04 00:00:00 |
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注册号状态: |
补注册 |
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Registration Status: |
Retrospective registration |
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注册题目: |
伴反刍思维的抑郁症患者静息态γ振荡功能连接特征研究 |
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Public title: |
Study on Resting-State Gamma Oscillation Functional Connectivity Characteristics in Depressive Patients with Rumination |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
伴反刍思维的抑郁症患者静息态γ振荡功能连接特征研究 |
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Scientific title: |
Study on Resting-State Gamma Oscillation Functional Connectivity Characteristics in Depressive Patients with Rumination |
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研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
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申请注册联系人: |
高盼盼 |
研究负责人: |
高盼盼 |
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Applicant: |
Gao Panpan |
Study leader: |
Gao Panpan |
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申请注册联系人电话: Applicant telephone: |
+86 159 3246 6445 |
研究负责人电话:
Study leader's |
+86 159 3246 6445 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
15932466445@163.com |
研究负责人电子邮件: Study leader's E-mail: |
15932466445@163.com |
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申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
河北省保定市东风东路572号 |
研究负责人通讯地址: |
河北省保定市莲池区河北省精神卫生中心 |
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Applicant address: |
No. 572 East Dongfeng Road, Baoding City, Hebei Province |
Study leader's address: |
No. 572 East Dongfeng Road, Baoding City, Hebei Province |
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申请注册联系人邮政编码: Applicant postcode: |
研究负责人邮政编码: Study leader's postcode: |
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申请人所在单位: |
河北省精神卫生中心 |
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Applicant's institution: |
Hebei Mental Health Center |
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研究负责人所在单位: |
河北省精神卫生中心 |
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Affiliation of the Leader: |
Hebei Mental Health Center |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
冀精伦审(科)202528号 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
河北省精神卫生中心医学伦理委员会 |
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Name of the ethic committee: |
Medical Ethics Committee of Hebei Mental Health Center |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-12-23 00:00:00 | ||
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伦理委员会联系人: |
李美芳 |
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Contact Name of the ethic committee: |
Li Meifang |
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伦理委员会联系地址: |
河北省保定市东风东路572号 |
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Contact Address of the ethic committee: |
No. 572 East Dongfeng Road, Baoding City, Hebei Province |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 312 507 9258 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
河北省精神卫生中心 |
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Primary sponsor: |
Hebei Mental Health Center |
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研究实施负责(组长)单位地址: |
河北省保定市东风东路572号 |
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Primary sponsor's address: |
No. 572 East Dongfeng Road, Baoding City, Hebei Province |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自筹及申请拨款 |
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Source(s) of funding: |
Self-funded and Applied for Grants |
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研究疾病: |
抑郁症 |
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Target disease: |
MDD |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
析因分组(即根据危险因素或暴露因素分组) |
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Study design: |
Factorial |
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研究目的: |
1.比较伴反刍思维抑郁组、不伴反刍思维抑郁组及健康对照组三组,在前额叶皮层、前扣带回γ振荡的绝对功率与相对功率、基于PLI的功能连接特征差异,探索伴反刍思维抑郁患者在大脑E/I平衡状态、及前额叶皮层-前扣带回的功能连接特征。 2.分析伴反刍思维抑郁症患者前额叶皮层、前扣带回γ振荡功率及PLI与反刍思维量表总分及子量表(症状反刍、沉思反刍、自我反思)得分的相关性,以期识别伴反刍思维抑郁症患者的γ振荡神经活动模式,检验“γ振荡异常 → 网络连接异常 → 反刍思维增强”的链式关系。 3.探索γ振荡特征是否可作为反刍思维严重程度的潜在生物标志物,为未来反刍症状的精准识别与神经调控干预(如rTMS)提供电生理依据。 |
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Objectives of Study: |
1. To compare the absolute and relative power of gamma oscillations in the prefrontal cortex and anterior cingulate cortex, as well as functional connectivity characteristics based on phase lag index (PLI), among three groups: depressed patients with rumination, depressed patients without rumination, and healthy controls; to explore the excitation/inhibition (E/I) balance and functional connectivity patterns of the prefrontal cortex–anterior cingulate cortex circuit in depressed patients with rumination. 2. To analyze the correlations between gamma oscillation power and PLI in the prefrontal cortex and anterior cingulate cortex and the total and subscale scores (symptom rumination, brooding, reflective pondering) of the rumination scale in patients with rumination-related depression, so as to identify the gamma oscillation neural activity patterns in these patients and verify the chain relationship: abnormal gamma oscillations → abnormal network connectivity → enhanced rumination. 3. To explore whether gamma oscillation characteristics can serve as potential biomarkers for the severity of rumination, and to provide electrophysiological evidence for the precise identification and neuromodulatory interventions (such as repetitive transcranial magnetic stimulation, rTMS) of rumination symptoms in the future. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
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Inclusion criteria |
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排除标准: |
抑郁组排除标准(满足一条即可排除): 1.既往有神经系统、严重的心血管系统、呼吸系统、免疫系统等疾病史; 2.合并其他精神障碍诊断者; 3.长期服用苯二氮䓬类药物(劳拉西泮剂量>2mg/天或是其他等效剂量同类药物)或测试前24小时内服用苯二氮䓬类药物、长期服用巴比妥类等影响GABA能系统作用的药物; 4.不能配合脑电采集者; 5.入组前3个月内或目前行经颅磁刺激治疗或MECT治疗的患者; 6.处于妊娠期的妇女。 健康组排除标准:同时满足抑郁组的排除标准。 |
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Exclusion criteria: |
Exclusion Criteria for the Depression Groups (Meeting any one of the following will result in exclusion) 1. Past history of neurological disorders, severe cardiovascular, respiratory, immune system diseases, or other major medical conditions; 2. Comorbid diagnosis of other psychiatric disorders; 3. Long-term use of benzodiazepines (lorazepam > 2 mg/day or equivalent doses of other benzodiazepines), or use of benzodiazepines within 24 hours before testing; long-term use of barbiturates or other drugs affecting the GABAergic system; 4. Inability to cooperate with electroencephalogram (EEG) data acquisition; 5. Patients who received repetitive transcranial magnetic stimulation (rTMS) or modified electroconvulsive therapy (MECT) within 3 months prior to enrollment or currently undergoing such treatments; 6. Pregnant women. Exclusion criteria for the healthy group: also meet the exclusion criteria for the depression group. |
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研究实施时间: Study execute time: |
从 From 2025-12-01 00:00:00至 To 2027-06-30 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2026-01-08 00:00:00 至 To 2027-06-30 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
无 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
none |
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是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: |
公开/Public |
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盲法: |
无 |
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Blinding: |
none |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
是Yes |
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共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址): |
研究公开发表后半年,邮件联系研究负责人合理获取。 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Six months after the publication of the research, contact the research leader via email to obtain reasonable information. |
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数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC: |
病例记录表 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
(Case Record Form, CRF |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |